Animal Studies to Support the Interpretation of Biomonitoring Data for Rare-Earth Metals

HEALTH CANADA ADVANCE CONTRACT AWARD NOTICE TITLE: Animal Studies to Support the Interpretation of Biomonitoring Data for Rare-Earth Metals SOLICITATION NUMBER: 1000181974 1. The Purpose and Explanation of an ACAN An Advance Contract Award Notice (ACAN) allows Health Canada contracting authorities to post a notice on the Government Electronic Tendering System (GETS), for no less than fifteen (15) calendar days, indicating to the supplier community that a good, service or construction contract will be awarded to a pre-identified contractor. If no other supplier submits, on or before the closing date, a Statement of Capabilities that meets the requirements set out in the ACAN, the contracting authority may then proceed with the award. However, should a Statement of Capabilities be found to meet the requirements set out in the ACAN, then the contracting authority will proceed to a full tendering process. 2. Rights of Suppliers Suppliers who believe that they are fully qualified and available to provide the services or goods described in this ACAN may submit a Statement of Capabilities clearly demonstrating how they meet the advertised requirement. This Statement of Capabilities must be provided via e-mail only to the contact person identified in Section 12 of the Notice on or before the closing date and time of the Notice. If there is a reasonable level of evidence regarding capability, the requirements will be opened to electronic or traditional bidding processes. 3. Proposed Contractor Université de Montréal Bureau Recherche - Développement - Valorisation 3744 rue Jean-Brillant Bureau 6320 Montréal (Québec) H3T 1P1 4. Definition of Requirements or Expected Results Evaluators in the Existing Substances Risk Assessment Bureau (ESRAB) and scientists in the Environmental Health Science and Research Bureau (EHSRB) identified four rare-earth metals (neodymium, yttrium, praseodymium, and cerium) which lack suitable toxicokinetic information needed to translate dose exposure of potential toxicity in laboratory rodents into human biomarker-equivalent metrics. The toxicity of these rare-earth metals is well-characterized in rodents, except for praseodymium, for which there is very limited data. Hence, in addition to toxicokinetics studies, investigation of the toxicity of praseodymium will be required to confirm and identify a safe dose to be converted into an equivalent biomarker level. The main objective of this project is to generate necessary laboratory animal data and develop toxicokinetic models to assess human biomonitoring measures relating to these 4 rare-earth metals (neodymium, yttrium, praseodymium, and cerium). The Contractor shall conduct literature reviews, design rat exposure protocols based on the Organization for Economic Cooperation and Development (OECD) Guidelines 417 and 407, perform laboratory animal exposure experiments, assess various toxicologically-relevant biological endpoints, quantify rare-earth metals in different biological matrices by ICP-MS, and develop the toxicokinetic models and biomonitoring equivalents (BEs) within the specified deadlines and the budget allocated for this project. Development of the toxicokinetic models by the Contractor will be based on data generated from the toxicokinetics and toxicology studies. The Contractor shall apply basic assumptions on exposure and toxicokinetics, along with newly obtained data, to generate simple models to translate exposure to the rare-earth metals into total biomarker levels in blood or total 24-hour urinary levels. Based on toxicology data from the literature and from this project, the Contractor will also derive BEs for the rare-earth metals assessed using an approach that will be very similar to that used in previous work on biomonitoring equivalents performed at Health Canada. 5. Minimum Requirements Any interested supplier must demonstrate by way of a Statement of Capabilities that it meets the following minimum requirements: 1) The expertise necessary to conduct literature reviews on rare earth metal toxicology and toxicokinetics, design animal exposure protocols based on OECD guidelines and develop toxicokinetic models and biomonitoring equivalents. 2) Animal housing facilities on the premises, as well as the clean room and ICP-MS analytical equipment to perform animal exposures and rare-earth metals quantifications; 3) Competent staff and expertise to perform laboratory animal exposure studies, ICP-MS quantification of rare-earth metals, and assessment of toxicological endpoints, including basic histopathology, haematology, clinical chemistry, and liver enzymatic activities; 4) Relevant experience in the area of toxicokinetics modeling and biomonitoring equivalents (BEs). This experience must be at a level that clearly demonstrates an ability to lead in the development of study design, toxicokinetics models and biomonitoring equivalents; 5) Relevant experience in interacting and collaborating with Health Canada stakeholders for the integration of toxicokinetic models and biomonitoring equivalents within existing Canadian risk assessments and for providing guidance at a senior project level in similar projects;

6) Adherence to tight deadlines and budgets set for these toxicology and toxicokinetics studies and for the development of four toxicokinetics models and biomonitoring equivalents. 6. Reason for Non-competitive Award Section 6 of the Government Contracts Regulations contains four exceptions that permit the contracting authority to set aside the requirement to solicit bids. For the proposed procurement, the following exception applies: (d) Only One Person or Firm is capable of performing the contract. Université de Montréal is the only service provider that meets all of the minimum requirements and complies with the specified tight deadlines and budgets. 7. Applicable Trade Agreements and Justification for Limited Tendering or the Procurement Strategy for Aboriginal Business This contract is a health study and therefore is not subject to either the North American Free Trade Agreement (NAFTA) or World Trade Organization - Agreement on Government Procurement (WTO-GPA). It is, however, subject to the Agreement on Internal Trade (AIT). This requirement is subject to limited tendering procedures in accordance with: AIT, Article 506.12 (b). which allows for contracts to be directed to a particular firm when the products or services can be supplied only by a particular supplier and no reasonable alternative or substitute exists. 8. Ownership of Intellectual Property Copyright shall vest with the Contractor, although the Contractor shall grant the Crown a license to exercise all Intellectual Property Rights in the Materiel for any public purpose. 9. Period of the Proposed Contract The contract period shall be from the date of contract award until March 31, 2017. 10. Estimated Value of the Proposed Contract The estimated value of the proposed contract is $260,000.00, including all applicable taxes. 11. Closing Date and Time The closing date and time for accepting Statements of Capabilities is the 10th of May 2016, 2 p.m. EST. 12. Contact Person All inquiries with regard to this Notice must be addressed by e-mail to: Name: Robert Merrick E-Mail: Robert.Merrick@hc-sc.gc.ca